Hemostatic clip holder

ABSTRACT

A clip holder for securely retaining a plurality of partially formed hemostatic clips prior to withdrawal of the clips by a clip applicator is constructed to provide a plastic housing having a generally rectangular opening therethrough and opposed inwardly directed shoulders at one end of the opening for supporting only the ends of the clips. A clip forming element having an outer surface configuration conforming to the contour of a completely formed clip is positioned within the housing in contact with the center of the clips, so that, the clips, upon withdrawal from the holder, must be completely formed against the forming element by the clip applicator.

United States Patent 1 Reimels 1 Jan.30,1973

[63] Continuation-impart of Ser. No. 38,986, May 20,

1970, abandoned.

Harry G. Reimels, Braintree, Mass.

[52] U.S. Cl ..206/56 DF, 72/410, 128/325 [51] Int. Cl ..A6lb 17/12,865d 83/00 [58] Field of Search ..29/212, 243.56; 72/410;

128/325, 334 R, 335; 206/56 R, 56 DF, 63.2 R; 221/198, 279; 227/19,95,120,136

[56] References Cited UNITED STATES PATENTS 1,746,495 2/1930 Palmgren..227/95 2,237,589 4/1941 Dole ..206/56 DF UX Wood ..128/325 O'Dett..206/56 DF X [57] ABSTRACT A clip holder for securely retaining aplurality of partially formed hemostatic clips prior to withdrawal ofthe clips by a clip applicator is constructed to provide a plastichousing having a generally rectangular opening therethrough and opposedinwardly directed shoulders at one end of the opening for supportingonly the ends of the clips. A clip forming element having an outersurface configuration conforming to the contour of a completely formedclip is positioned within the housing in contact with the center of theclips, so that, the clips, upon withdrawal from the holder, must becompletely formed against the forming element by the clip applicator.

20 Claims, 20 Drawing Figures PATENTEUJAHBO 1975 3, 7 1 3; 533

SHEET 1 BF 3 M BWZM WW3}? i INVENTOR R a W PATENTEUJMI 30 I973 SHEET 2BF 3 INVENTOR.

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BACKGROUND OF THE INVENTION This is a continuation-in-part ofapplication Ser. No.

38,986, filed May 20, 1970 now abandoned, This invention relates tohemostatic clips and, more particularly, the invention relates to a clipholder for securely retaining a plurality of hemostatic clips prior towithdrawal of the clips by a clip applicator.

The use of clips for clamping blood vessels during a surgical operationis a well known practice and specific clip and clip holder constructionshave been the subject matter of many previous patents. For example, US.Pat. No. 3,326,216 illustrates a specific hemostatic clip constructionand the preferred method for positioning the clip relative to a bloodvessel. The patent also shows a magazine or holder for supporting anumber of clips in a suitable position for withdrawal by a clipapplicator. Since the clips are extremely small, it is necessary toprovide such a holder to facilitate handling and alignment of the clipswith the clip applicator.

Although the clip holder described in the abovecited patent provides animproved device for storing and handling hemostatic clips, it has beenfound that clips stored in this manner have a tendency to becomeloosened during shipping and handling and may be completely dislodgedfrom the clip holder. This is true because the device relies entirelyupon the frictional contact between the clips and the holder to retainthe clips therein. Also, even a slightly loosened clip may move out ofalignment and create difficulties for the surgeon in his attempt towithdraw the clip with a clip .applicator.

United States Pat. No. 3,270,745 describes a clip holder whichpositively retains the preformed clips, however, it is not clearlystated in this patent how the clips may be effectively removed from theholder. It would appear that the inner action of the jaws of the forcepswould counteract the outward deformation of the clip, which deformationis necessary to effect removal of the clip from the holder. In addition,the inherent spring action of the clip would tend to eject the clip fromthe inner faces of the applicator jaws after removal of the clip fromthe magazine.

Heretofore, there were no known hemostatic clip holders that combinedthe desirable qualities of total retention of the clips during shippingand handling with the relative ease of the withdrawal of the clips by aclip applicator.

SUMMARY OF THE INVENTION The present invention furnishes the desirablequalities stated above by providing a clip holder that positively locksthe ends of the clip within an opening formed in the holder. A clipforming element bears against the inner, central portion of the clip toform an anvil against which the clip must be formed by the clipapplicator prior to withdrawal of the clip from the holder.

With this type of construction, it is absolutely impossible for theclips to become dislodged from the holder and the clips are always heldin a predetermined position for alignment with the clip applicator. Themanipulative procedure required for complete formation and release ofthe clip is an inward thrust of the clip applicator which accomplishesthe desired bending of the partially formed clip around the clip-forminganvil. It is then only necessary to pull the applicator from the holderand the completely formed clip will be retained within the jaws of theapplicator by the outward spring action of the clip in a position forapplication to a blood vessel or other body member. The inventionfurther contemplates the use of positive gripping means on the ends ofthe hemostatic clips which coact with complementary means on the innersurfaces of the applicator jaws to positively retract the clips from theholders.

DESCRIPTION OF THE DRAWINGS The invention will be particularly describedwith reference to the following detailed description of the preferredembodiment of the invention when considered together with the attacheddrawings, in which:

FIG. I is a perspective view illustrating the clip holder of the presentinvention together with a clip applicator in position for withdrawal ofa clip from the holder;

FIG. 2 is a perspective view showing the main elements of the clipholder and a clip in position for placement into the holder;

FIG. 3 is a cross sectional view of the housing portion shown in FIG. 2with a clip positioned for placement into the housing;

FIG. 4 is a cross sectional view ofa housing similar to FIG. 3illustrating a clip supported within the housing and the clip formingelement in position for placement within the housing;

FIG. 5 is a cross sectional view of the housing and clip forming elementpositioned relative to one another with a clip held firmly therebetween;

FIG. 6 is a top plan view of the housing portion of the clip holdershown in FIG. 2;

FIG. 7 is a cross sectional view of the housing portion shown in FIG. 6taken along line 7-7;

FIG. 8 is a side view of the housing portion of the holder shown in FIG.6;

FIG. 9 is a fragmentary cross sectional view showing the position of theclips within the housing portion of the holder; 7 4

. FIG. 10 is a fragmentary cross sectional view taken along line 10-10in FIG. 1 and illustrating in phantom the position of a completelyformed clip relative to the clip applicator after withdrawal thereoffrom the clip holder;

FIG. 11 is a fragmentary perspective view of the completely formed clipand clip applicator in the withdrawn position;

FIG. 12 is an enlarged cross sectional view of the end portion of theclip applicator showing a completely formed clip positioned between thejaws thereof;

FIG. 13 is a cross sectional view taken along line 13l3 in FIG. 12;

FIG. 14 illustrates the position of a clip after it has been applied toa blood vessel;

FIG. 15 is a side view of another embodiment of the hemostatic clipshowing positive gripping means on the ends thereof;

FIG. 16 is a cross sectional view showing the clip of FIG. 15 supportedwithin the holder of the present invention and a clip applicator havingcomplementary gripping surfaces on the ends of its jaws;

FIG. 17 is a cross sectional view of the end portion of the clipapplicator having a completely formed clip positioned between the jawsthereof; and

FIGS. l8, l9 and 20 illustrate further embodiments of the hemostaticclip of FIG. 15.

Referring to FIG. 1, the clip holder of the present invention is showngenerally at 10 and is illustrated as being held between the forefingerand thumb of a surgeon or nurse. A clip applicator 11 is held in theother hand of the surgeon in a position best suited to completely formand withdraw a clip from the clip holder. The internal construction ofthe clip holder 10 may best be seen in FIG. 2 wherein the individualcomponents of the holder are shown in position for the loading of a clipinto the holder. The main component of clip holder 10 is a housing 12which is preferably constructed ofa rigid plastic material. Housing 12has a generally rectangular opening 13 passing therethrough forreceiving the plurality of clips that are to be retained therein by aclip forming element 14.

Housing 12 is shown in a cross sectional view in FIG. 3 as having agenerally box-like configuration with two opposed side walls 15 and twoopposed end walls 16. The upper portion of housing 12 has an outwardlyextending flange 17 which facilitates handling of the holder andprovides a more sturdy construction. The lower portion of housing 12 isconstructed with opposed inwardly extending shoulders 18 and 19 whichare adapted to support a clip 20 (see FIG. 2) which is dimensioned tofit within the housing and be supported across the lower portion ofopening 13 by the shoulders.

The detailed construction of housing 12 is shown more specifically inFIGS. 6-8 wherein the basic boxlike structure formed by walls 15 and 16has a central opening 13 passing therethrough and is reinforced at itsupper rim by outwardly extending flange 17. A plurality of spacerelements 21 are secured between walls 15 and divide opening 13 into aplurality of spaces, each of which has a portion of shoulders 18 and 19extending thereinto. Actually, shoulder 18, as well as shoulder 19, maybe considered to be a single inwardly extending shoulder or as aplurality ofindividual inwardly extending shoulders separated by spacerelements 21. Spacer elements 21 not only partition housing 12 into aplurality of clip receiving spaces, but also facilitate the assemblingof the entire clip holder by providing individual pockets 24 into whichthe clips may be placed. To further facilitate the positioning of theclips, pockets 24 are tapered upwardly as at the inclined portion 25 andform a bottom width essentially equal to the width of clip 20 (see FIG.9).

A slot 26 is formed in each spacer element 21 and the slots are allaligned to form a channel 27 for receiving clip forming element 14. Thearcuately shaped portions 30 of spacer elements 21 extend outwardly fromopening 13 and provide a guiding means for the tips of the clipapplicator 11 to assure that the applicator will be properly alignedwith the clip 20.

The assembly of clips 20 within the clip holder 10 is best illustratedin FIGS. 3 to 5 which show the sequential steps of positioning clips 20within opening 13 and supporting the ends of the clips across theopening by shoulders 18 and 19. After each clip 20 has been properlypositioned within a pocket 24, the clip forming element 14 is broughtinto position within channel 27 and thereafter into contact with theclips 20 which are suspended across opening 13 by shoulders 18 and 19.Referring to FIG. 4, clip forming element 14 is constructed in agenerally T-shaped configuration with an upper portion 35 which conformsin cross sectional configuration to the upper portion of opening 13 andis designed to have a press-fit within the opening with walls 15 and 16.Depending from block 35 is a projection 36 that is designed to fitclosely within channel 27. Projection 36 forms the clip forming elementor anvil around which the clips must ultimately be formed prior towithdrawal of the clips by the clip applicator l 1.

Referring to FIG. 2, the outermost end of projection 36 is illustratedmore clearly and the end is shown with a plurality of indentation 37which are designed to be in alignment with the pockets 24 and clips 20located therein. This construction further facilitates the alignment ofthe essential parts of the clip holder and assures that the clips 20will be maintained in a predetermined position for withdrawal by theclip applicator.

Referring again to FIG. 5, the clip holder 10 is shown in its completelyassembled condition with one of the clips 20 suspended at its ends onshoulders 18 and 19 across opening 13 and with clip forming projection36 contacting its approximate center on the side of the clip oppositethe side that is contacted by the shoulders. The insertion of clipforming element 14 into opening 13 forces the projection or anvil 36against the center of the clip and causes the clip to be deformed into aV- shape and to be held firmly in said shape and to be retained securelywithin clip holder 10. It will be understood that clips must be insertedwithin each of the pockets 24 and suspended across shoulders 18 and 19prior to the positioning of clip forming element 14 within opening 13.The downward movement (as viewed in FIG. 5) of the anvil or projection36 will thereby contact each of the clips and deform each clip uniformlyto accomplish the desired result.

It will be apparent from the foregoing description that it is impossiblefor clips 20 to be removed, either intentionally or accidentally, fromclip holder 10 without further deformation of the clips. Therefore, theclips cannot be accidentally loosened or dislodged from the clip holderduring shipping or handling of the product.

When it is desired to utilize the clips during a surgical procedure, thesurgeon must only insert the tips of clip applicator 11 between theindividual clip applicator guiding means 30 and into contact with aparticular clip 20. Clip applicator 11 (see FIG. 11) is constructed sothat the tips 40 and 41 ofjaws 42 and 43, respectively, are reduced inthickness so that they have a width approximately the same as theclearance formed between adjacent guide means 30. The preferred clipapplicator is illustrated with this invention in the form of forcepshaving a pair of pivotally connected arms 45 and 46 which terminate injaws 42 and 43, respectively. The operating end of arms 45 and 46 haveconventional ring-type gripping members and the jaws are held in apredetermined spaced position by a leaf spring 47 and a stop means 48located between the ring members 49 and 50. This arrangement insuresthat the tips 40 and 41 will be in a properly spaced position forinsertion into the clip holder 10.

When it is desired to remove a clip from the clip holder, it is onlynecessaryfor the surgeon to grasp the clip holder and the clipapplicator and to thrust the tips of the applicator into one of thespaces provided between guide means 30 and into contact with thesuspended arms of a clip 20. This procedure accomplishes the furtherdeformation of clip 20 thus placing it in a completely formed conditionand also releases the suspended ends of the clip from shoulders 18 and19 thereby rendering it possible for the clip applicator to withdraw theclip from the holder as illustrated in the phantom view of FIG. 10. Aswill be seen more clearly in FIGS. 12 and 13, tips 40 and 41 areconstructed with channels 52 and 53, respectively, in the ends thereofto provide a gripping surface for retaining the withdrawn clip 20therebetween. Because the suspended arms of the clip must be deformedinwardly in order to effect removal of the clip from the clip holder,the arms will have a natural tendency to spring outwardly into contactwith the inner gripping surfaces of tips 40 and 41 and thus be heldfirmly between the tips. The construction of tips 40 and 41 is notcritical, however, as shown in FIG. 13, it is desirable to have thechannels 52 and 53 shallower than the thickness of clip 20 so that tips40 and 41 will not exert a cutting action on the blood vessel when clip20 is applied thereto.

The remaining clips may be left in clip holder or withdrawn therefrom asneeded during the surgical operation. One such clip 20 is shown inclamping position around a blood vessel 54 in FIG. 14.

In some instances, it has been found to be desirable to provide positivegripping means on the outer ends of the hemostatic clips andcomplementary gripping means on the inner ends of the applicator jaws.This construction is best illustrated in FIGS. 15-17. Referring to FIG.15, a clip a, shown in the configuration it takes when supported inholder 10, has a plurality of projections 60a in the form of saw teethextending outwardly from the ends thereof. When clip 20a is supported inholder 10 between shoulders 18 and 19, as shown in FIG. 16, projections60a extend outwardly in a position to be contacted by complementaryprojections 61 on the inner ends of the applicator jaws 40a and 41a. Ameshing of the projections 60a and 6] occurs when the applicator jawsare forced into the holder and clip 20a is held firmly between the jaws,as illustrated in FIG. 17, when the applicator is withdrawn from theholder. Thus, in addition to the outward spring action of clip 20a, apositive gripping means is provided to prevent accidental ejection ofthe clip from the applicator.

FIGS. l8, l9 and 20 illustrate additional embodiments of the hemostaticclip construction shown in FIG. 15. The clips 20b, 20c, and 20d areequipped on the outer ends thereof, respectively, with projections 60b,60c and 60d which are designed to cooperate with complementaryprojections (not shown) on the inner ends of suitable clip applicators.All of the projections are, of course, designed to assist the springaction of the clip to retain the clip more securely in the applicatoraws.

The material from which the clip of this invention is constructed is notcritical, however, it is preferably formed of surgical metals which arenontoxic and which therefore can be tolerated within the body forindefinite periods of time. The preferred clip material for thisinvention is tantalum, however, stainless steel is an equally effectivematerial. The material from which the clip holder 10 is constructed isalso not critical, however, it is preferred to utilize a fairly rigidsterilizable plastic material that may be injection molded in a suitablemanner. Examples of such plastic materials are acetal and polycarbonate.

It will be apparent from the foregoing description, that a uniquehemostatic clip holder construction has been provided that yieldsseveral advantages over any previously known device. The unique mannerin which the clips are stored within the holder positively eliminatesthe possibility that the clips will become misaligned or dislodged fromthe holder. On the other hand, it is a relatively simple matter toremove the clips from the holder when it is desired to utilize the clipsin a surgical procedure.

What is claimed is:

1. A clip holder securely retaining a hemostatic clip prior towithdrawal of said clip by a clip applicator comprising:

1. a housing having a pair of spaced clip supporting members defining anopening therebetween;

2. a partially formed clip supported across said open- I ing only at itstwo ends by said members; and

3. a clip forming element mounted in said housing and having aprojection with an outer'configuration conforming to the desired contourof a completely formed clip, said projection being in contact with theapproximate center of said partially formed clip on the side of saidclip opposite said supporting members.

2. The clip holder of claim 1 wherein said clip forming elementeffectively forces the ends of said clip into contact with said supportmembers.

3. The clip holder of claim 2 wherein said clip forming element extendspartially through said opening and said clip is formed and held therebyinto a V-shape.

4. The clip holder of claim I wherein said housing has a plurality ofpairs of clip supporting members defining an opening therebetween, eachpair of members supporting an individual clip across said opening.

5. The clip holder of claim 4 wherein each pair of clip supportingmembers is equipped with a clip centering means properly positioningsaid clip within said housing.

' 6. The clip holder of claim 5 further comprising spacer elementsmounted in said housing between adjacent pairs of clip supportingmembers, each of said spacer elements having a slot therein receivingsaid clip forming element. a

7. The clip holder of claim 6 wherein said slots are aligned to form achannel overlying said clips.

8. The clip holder of claim 1 wherein said clip has at least oneprojection extending outwardly from each of its two ends in thedirection of said supporting members for meshing with complementaryprojections on the jaws of said clip applicator.

9. The clip holder of claim 8 wherein each end of said clip has aplurality of projections.

10. The clip holder of claim 9 wherein said clip projections are in theform of saw teeth.

11. A clip holder securely retaining a plurality of hemostatic clipsprior to withdrawal of said clips by a clip applicator comprising:

1. a housing having a generally rectangular opening therethrough;

2. inwardly directed shoulders on opposite sides of one end of saidopening;

3. a plurality of partially formed clips within said housingsimultaneously supported at their ends across said opening by saidshoulders, and

4. means within said housing forcing the ends of each of said clipsagainst said shoulders.

12. The clip holder of claim 11 wherein said means contacts the side ofeach clip opposite its supported ends.

13. The clip holder of claim 12 wherein said means contacts only theapproximate center of said clips.

14. The clip holder of claim 13 wherein said means is a clip formingelement which has an outer surface configuration conforming to thedesired contour of a completely formed clip.

15. The clip holder of claim 14 wherein the portion of said clip formingelement in contact with said clips extends outwardly from said housingbetween said shoulders and forms said clips into a a V-shape.

16. The clip holder of claim 15 further comprising clip centering meanslocated on said shoulders properly positioning said clips.

17. The clip holder of claim 16 further comprising spacer elementsmounted in said housing between said clip centering means, each of saidspacer elements having a slot receiving said clip forming elements.

18. The clip holder of claim 17 further comprising a clip applicatorguide secured to each of said spacer elements and extending outwardlyfrom said housing between said shoulders.

19. The clip holder of claim 16 wherein said clip forming element has aplurality of grooves in alignment with said clip centering means furtherpositioning said clips.

20. The clip holder of claim 19 wherein said clip forming element is inthe form of a projection which is integral with a substantiallyrectangular block that is securely fitted within the other end of saidrectangular opening.

l I i l

1. a housing having a generally rectangular opening therethrough;
 1. Aclip holder securely retaining a hemostatic clip prior to withdrawal ofsaid clip by a clip applicator comprising:
 1. a housing having a pair ofspaced clip supporting members defining an opening therebetween;
 2. apartially formed clip supported across said opening only at its two endsby said members; and
 3. a clip forming element mounted in said housingand having a projection with an outer configuration conforming to thedesired contour of a completely formed clip, said projection being incontact with the approximate center of said partially formed clip on theside of said clip opposite said supporting members.
 1. A clip holdersecurely retaining a hemostatic clip prior to withdrawal of said clip bya clip applicator comprising:
 1. a housing having a pair of spaced clipsupporting members defining an opening therebetween;
 2. a partiallyformed clip supported across said opening only at its two ends by saidmembers; and
 2. inwardly directed shoulders on opposite sides of one endof said opening;
 2. The clip holder of claim 1 wherein said clip formingelement effectively forces the ends of said clip into contact with saidsupport members.
 3. The clip holder of claim 2 wherein said clip formingelement extends partially through said opening and said clip is formedand held thereby into a V-shape.
 3. a plurality of partially formedclips within said housing simultaneously supported at their ends acrosssaid opening by said shoulders, and
 3. a clip forming element mounted insaid housing and having a projection with an outer configurationconforming to the desired contour of a completely formed clip, saidprojection being in contact with the approximate center of saidpartially formed clip on the side of said clip opposite said supportingmembers.
 4. means within said housing forcing the ends of each of saidclips against said shoulders.
 4. The clip holder of claim 1 wherein saidhousing has a plurality of pairs of clip supporting members defining anopening therebetween, eaCh pair of members supporting an individual clipacross said opening.
 5. The clip holder of claim 4 wherein each pair ofclip supporting members is equipped with a clip centering means properlypositioning said clip within said housing.
 6. The clip holder of claim 5further comprising spacer elements mounted in said housing betweenadjacent pairs of clip supporting members, each of said spacer elementshaving a slot therein receiving said clip forming element.
 7. The clipholder of claim 6 wherein said slots are aligned to form a channeloverlying said clips.
 8. The clip holder of claim 1 wherein said cliphas at least one projection extending outwardly from each of its twoends in the direction of said supporting members for meshing withcomplementary projections on the jaws of said clip applicator.
 9. Theclip holder of claim 8 wherein each end of said clip has a plurality ofprojections.
 10. The clip holder of claim 9 wherein said clipprojections are in the form of saw teeth.
 11. A clip holder securelyretaining a plurality of hemostatic clips prior to withdrawal of saidclips by a clip applicator comprising:
 12. The clip holder of claim 11wherein said means contacts the side of each clip opposite its supportedends.
 13. The clip holder of claim 12 wherein said means contacts onlythe approximate center of said clips.
 14. The clip holder of claim 13wherein said means is a clip forming element which has an outer surfaceconfiguration conforming to the desired contour of a completely formedclip.
 15. The clip holder of claim 14 wherein the portion of said clipforming element in contact with said clips extends outwardly from saidhousing between said shoulders and forms said clips into a a V-shape.16. The clip holder of claim 15 further comprising clip centering meanslocated on said shoulders properly positioning said clips.
 17. The clipholder of claim 16 further comprising spacer elements mounted in saidhousing between said clip centering means, each of said spacer elementshaving a slot receiving said clip forming elements.
 18. The clip holderof claim 17 further comprising a clip applicator guide secured to eachof said spacer elements and extending outwardly from said housingbetween said shoulders.
 19. The clip holder of claim 16 wherein saidclip forming element has a plurality of grooves in alignment with saidclip centering means further positioning said clips.